Multiple sclerosis or MS is a chronic disease that affects the brain and spinal cord resulting in loss of muscle control, balance, and sensation (such as numbness). Currently, the exact cause of MS remains unknown, but researchers believe that a combination of several factors may be involved. It is believed that MS appears in genetically predisposed individuals possibly in the presence of specific external factors which lead to the development of MS. It is now generally accepted that MS involves an autoimmune process—an abnormal response of the body's immune system that is directed against the myelin (the fatty sheath that surrounds and insulates the nerve fibers) in the central nervous system (CNS—the brain, spinal cord and optic nerves). MS results in a thinning or complete loss of myelin and, as the disease advances, the cutting (transection) of the neuron's extensions or axons. When the myelin is lost, a neuron can no longer effectively conduct electrical signals. A repair process, called remyelination, takes place in early phases of the disease, but the cell's myelin sheath cannot be completely rebuilt. Repeated attacks lead to successively fewer effective remyelinations, until a scar-like plaque is built up around the damaged axons.
Apart from demyelination, the other pathologic trait of the disease is inflammation. According to a strictly immunological explanation, the inflammatory process is caused by T cells, a kind of lymphocyte. Lymphocytes are cells that play an important role in the body's defenses. In MS, T cells gain entry into the brain via the blood—brain barrier. It is believed that the T cells recognize myelin as foreign and attack it which triggers inflammatory processes, stimulating other immune cells and soluble factors like cytokines and antibodies.
In addition to autoimmune disorder, some researchers believe that infections may somehow trigger the immune system to attack nerve cells. Basically, it is believed that the virus (or a bacterium) that causes an initial infection “looks” like a nerve cell. The immune system develops T-cells to fight off the virus. Those T-cells remain in the body after the infection is gone and become confused when they “see” a nerve cell, mistaking it for an invader. The result is that your immune system attacks the nervous system.
There are four main varieties of MS. 1. Relapsing/Remitting (RRMS): characterised by relapses during which time new symptoms can appear and old ones resurface or worsen. 2. Secondary Progressive (SPMS): characterized by a gradual worsening of the disease between relapses. 3. Progressive Relapsing Multiple Sclerosis (PRMS): This form of MS follows a progressive course from onset, punctuated by relapses. 4. Primary Progressive (PPMS): This type of MS is characterized by a gradual progression of the disease from its onset with no remissions at all.
There is no known cure for MS at this time. However, there are therapies that may slow the disease. The goal of treatment is to control symptoms. Medications that alter the immune system, for example interferons, have been used to manage multiple sclerosis. Interferons are protein messengers that cells of the immune system manufacture and use to communicate with one another. There are different types of interferons, such as alpha, beta, and gamma. All interferons have the ability to regulate the immune system and play an important role in protecting against intruders including viruses. Each interferon functions differently, but the functions overlap. The beta interferons have been found useful in managing multiple sclerosis.
There is a continuing need for new drug products with desired therapeutic efficacy for treatment of MS and related symptoms.
The therapeutic effect of an extremely diluted form (or ultra-low form) of antibodies potentized by homeopathic technology (activated potentiated form) has been discovered by the inventor of the present patent application, Dr. Oleg I. Epshtein. U.S. Pat. No. 7,582,294 discloses a medicament for treating Benign Prostatic Hyperplasia or prostatitis by administration of a homeopathically activated form of antibodies to prostate specific antigen (PSA).
The S-100 protein is a cytoplasmic acidic calcium binding protein found predominantly in the gray matter of the brain, primarily in glia and Schwann cells. The protein exists in several homo- or heterodimeric isoforms consisting of two immunologically distinct subunits, alpha and beta. The S-100 protein has been suggested for use as an aid in the diagnosis and assessment of brain lesions and neurological damage due to brain injury, as in stroke. Yardan et al., Usefulness of S100B Protein in Neurological Disorders, J Pak Med Assoc Vol. 61, No. 3, March 2011, which is incorporated herein by reference.
Ultra low doses of antibodies to S-100 protein have been shown to have anxiolytic, anti-asthenic, anti-aggressive, stress-protective, anti-hypoxic, anti-ischemic, neuroprotective and nootropic activity. See Castagne V. et al., Antibodies to S100 proteins have anxiolytic-like activity at ultra-low doses in the adult rat, J Pharm Pharmacol. 2008, 60(3):309-16; Epstein O. I., Antibodies to calcium-binding S100B protein block the conditioning of long-term sensitization in the terrestrial snail, Pharmacol Biochem Behav., 2009, 94(1):37-42; Voronina T. A. et al., Chapter 8. Antibodies to S-100 protein in anxiety-depressive disorders in experimental and clinical conditions. In “Animal models in biological psychiatry”, Ed. Kalueff A. V. N-Y, “Nova Science Publishers, Inc.”, 2006, pp. 137-152, all of which are incorporated herein by reference.
Ultra low doses of antibodies to gamma interferon have been shown to be useful in the treatment and prophylaxis of treating a disease of viral origination. See U.S. Pat. No. 7,572,441, which is incorporated herein by reference in its entirety.